Resource Hub

1. How can I get involved in a clinical trial?
   1. The most important thing to do is to speak to your doctor. They will have the best understanding of your diagnosis and should be able to direct you to any clinical trials that you would be eligible to participate in.
   2. There are other resources you can use to research clinical research and active trials. We’ve included a list of these on our patient’s page HERE.
2. What if the trial I am involved with isn’t using a home trial service?
   1.  Speak to your doctor and see if there is the option to use a home visit service. Your doctor will want to understand your challenges and support you as much as possible.
3.  Is it safe with COVID-19?
   1. All our healthcare professionals that undertake visits at home complete a COVID-19 test before the visit and wear full PPE during the visit. MRN do everything possible to ensure your safety, if being seen by one of our team in your home.
4. What do I have to do for a trial visit at home?
   1. Our research staff are fully trained and understand what they need to do to keep you safe and compliant with the study visit requirements.
      They are equipped with everything required to complete the study visit with you and will liaise with the courier on your behalf.
      Our team will contact you before the visit to make sure the time and date are convenient for you and to check how you’re doing.
      All we ask is that you provide them with a clean, safe place to put everything and keep the space where they will be working free of pets.
      For more information on what to expect from a home visit take a look at our home visit animation HERE

1. How quickly are home trial support visits initiated and arranged during studies?
   1. MRN recognizes the urgency that the COVID-19 pandemic and travel restrictions have placed on ongoing clinical trials and have received multiple requests for assistance. As a result, we have developed a streamlined approach to evaluating and operationalizing these requests for support. This is a non-standard process that has been developed specifically to address these urgent needs in response to the current crisis.
   2. In order to evaluate the viability of Home Trial Support (HTS) for our clients ongoing studies, we will need the following documents:
      1. Request noting that this is COVID-19 Related
      2. Final Protocol
      3. Investigator Brochure
      4. Lab manual
      5. Pharmacy Manual
      6. Master ICF
      7. Study timelines
      8. Status overview of countries/sites/subjects
      9. Specific visits and activities to be conducted for the HTS visit
   3. Following a request for support (including the documents listed above), our process begins with a ‘rapid response’ meeting between our SMEs and the CRO/Sponsor to discuss the specific study needs and to ascertain feasibility for HTS services. This rapid response meeting will likely be held 24-72 hrs. after the request is submitted.
   4. Following the meeting, and assuming it is feasible to provide the support requested, MRN will develop a working framework and issue a ballpark budget and Letter of Intent (LOI). We expect that process will be completed in 48-72 hours following the meeting.
   5. The streamlined approach we have designed is intended to be able to deliver visits within 5-7 weeks (c.f the standard 12-15 week set-up). The achievement of the accelerated timeline is contingent on the sponsor and/or CRO making an immediate commitment based on the ballpark budget and LOI.
   6. Due to the dynamic and iterative nature of responding in an urgent manner, we will be unable to provide a full and final budget at the time of the LOI. Our recommendation is to be as pro-active as possible during set-up so that the trial can be set up everywhere that you may need support and prevent the inefficient, and costly, chasing of the impact of the current crisis on your trial.
   7. With respect to regulatory issues, it appears that IRB/EC are sympathetic to the need for home visits in order to protect the safety of subjects. To date, we have received no negative feedback from regulatory authorities and ethics committees. However, it will be up to each study team to determine the regulatory acceptability of HTS visits for their study.
   8. The accelerated timelines will require the availability of your clinical team to provide timely document review and approval, as needed, during the set-up process
   9. Prior to the first HTS visit, we will need a full contract in place
2. Can HTS be used where previously it was not considered?
   1. FDA: Since trial participants may not be able to come to the investigational site for protocol-specified visits, sponsors should evaluate whether alternative methods for safety assessments (e.g., phone contact, virtual visit, alternative location for assessment, including local labs or imaging centres) could be implemented when necessary and feasible, and would be sufficient to assure the safety of trial participants. Sponsors should determine if in-person visits are necessary to fully assure the safety of trial participants (for example to carry out procedures necessary to assess the safety or the safe use of the investigational product appropriately); in making the decision to continue use or administration of the investigational product, the sponsor should consider whether the safety of trial participants can be assured with the implementation of the altered monitoring approach. If scheduled visits at clinical sites will be significantly impacted, certain investigational products, such as those that are typically distributed for self-administration, may be amenable to alternative secure delivery methods. For other investigational products that are normally administered in a health care setting, consulting FDA review divisions on plans for alternative administration (e.g., home nursing or alternative sites by trained but non-study personnel) is recommended. In all cases, existing regulatory requirements for maintaining investigational product accountability remain and should be addressed and documented.
   2. EMA: Where a trial participant is unable to attend the site, other measures, such as home nursing, if possible given social distancing needs, or contact via phone or telemedicine means, may be required to identify adverse events and ensure continuous medical care and oversight. However, the limitations and risks of such methods and the requirements for data protection should be considered and such alternative arrangements need to be adequately documented. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf
   3. UK: If patient visits need to be moved, the options are to set up as a sub-contracted site of the existing site if oversight can be maintained by the existing site, or to set up new sites, or to implement direct home care arrangements by the sponsor. For study types where the addition of new sites is a substantial amendment, existing guidance for submitting a substantial amendment for new sites should be followed. In all other cases, existing guidance for non-substantial amendments and addition of new sites should be followed.                                                                                                                                            https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/covid-19-guidance-sponsors-sites-and-researchers/

1. What is eSource?
   1. The FDA defines eSource as “any combination of text, graphics, data, audio, pictorial or other information represented in a digital form that is created, modified, maintained, archived, retrieved or distributed by a computer system”.
2. What are the benefits of eSource?
   1. By using eSource, researchers can produce consistent and legitimate data, as source data will be electronic from the start of the research process, reducing the risk of submission errors. Additionally, the source data can be made easily available to sponsors and CROs for remote monitoring, as opposed to scanning in paper sources.
3. What is Direct Data Capture (DDC)?
   1. DDC is direct data entry into a DDC tool or platform in real time when the patient is still present, and errors can still be corrected. It also includes DDC for other types of information collected during a clinical trial, such as vital signs, ECG, and blood or urine screens or other protocol defined assessments.
4. What is electronic data capture process (EDC)?
   1. An EDC system is a web-based software platform designed for the collection of clinical data in electronic format and then provides tools to clean, transfer and process data for clinical trials.
5. What is electronic Patient Reported Outcome (ePRO)?
   1. When patients use ePROs in trials, they can answer questions and give reports throughout a trial. These are usually done on electronic devices such as a tablet, a smartphone designated for a study or through an app on a patient’s personal device.
6. What are the benefits of MRNs eSource/DDC platform and processes?
   1. Improves data security at collection
   2. Ensures saved source data is synchronized on data connection, even when captured offline
   3. Reduces data entry errors and data queries
   4. Eliminates unnecessary data duplication
   5. Enhances PI oversight to show the complete picture of a patient’s data
7. What devices do your healthcare professionals use?
   1. All MRN healthcare professionals (HCP) are provided with a cellular enabled iPad for eVRF completion at home trial support visits. These iPads have connectivity to cellular data services and Wi-Fi access. Additionally, the devices possess security elements to ensure only the authorized HCP can use the iPad. The iPads are also locked in terms of usage and restricted from downloading non-approved applications to ensure the iPads are not exposed to security risks.
8. What is the impact to MRN’s study setup time and the time required to effect any changes if there are mid-study changes to the protocol?
   1. Setup time is within the normal project start-up timeline, this is the same for mid-study changes. Once any change is deployed the MRN app will pick it up, so there is no additional lead time for the HCP to wait for new copies of a paper VRF and the app will always use the most current eVRF version.
9. Will MRN continue to provide paper based VRFs as a back-up?
   1. With the launch of our eSource system, we will no longer offer or provide paper VRFs for new studies. Existing studies will continue to use the existing paper VRFs as source data. And some existing processes will continue to use paper forms – the SRF, POF, DTSP and LabReq forms. For our full statement on this please contact us.
10. Who do you partner with?
    1. MRN are device agnostic which means we can use any system the customer desires, or we can recommend the solution most appropriate for the study design. MRN partner with all the leading telemed providers.

If you want to learn more about MRN & DCT in Japan contact us HERE

1. What precautions have been put in place for home visits with regards to the Covid-19 pandemic?
   1. Healthcare professionals (HCP) complete a rapid lateral flow test prior to every visit, or weekly if they are completing more than one visit per month. HCP can only perform the visit if their test is negative. Test status is tracked and stored by MRN.
   2. HCPs contact the subject 24 hours before the visit is to take place to ensure they are still available. At this point the HCP runs through screening questions for COVID symptoms with the patient.
   3.  Based on national and internal guidelines, MRN has instructed all HCP conducting home visits to follow the following standards:
      1. Aprons, gloves and surgical face masks should always be worn for HTS visits.
      2. Handwashing must be thorough, with water (hot if possible) and soap and last at least 20 seconds. If clean water is not available, use hand sanitizer gel.
      3. Disposable paper towels should be used to dry hands for all visits.
      4. Hand sanitizer gel (or anti-bacterial hand wipes where provided) should be used between handwashes and as you enter or leave the home.
      5. Courier delivery – Per our standard HTS process, the courier driver is not allowed to enter the patient’s home during delivery of IMP or collection of laboratory samples. The HCP will interact with the courier outside the patient’s home and will adhere to the social distancing guidelines whilst interacting with the driver.
2. How are you ensuring sufficient resources and safety equipment such as PPE where necessary during the COVID-19 pandemic?
   1. We are monitoring our supplies vendors closely to ensure that we are aware at the earliest opportunity when essential items might be becoming more difficult to source or when we might experience delays in items being dispatched and delivered to MRN. We have plans in place to ensure, as much as possible, that we are ahead of any potential shortages. We have buffers in place for what we believe to be those items required regularly by HCP who are continuing to support home visits.
3. How are MRN overcoming the travel restrictions due to the pandemic?
   1. MRN and our vendors are following per country National and Local Health Authority Guidance related to travel within impacted regions or where restrictions have been applied. Currently, any travel restrictions do not apply to HCP or services related to delivery of healthcare. MRN has issued HCPs with ‘letters of authorisation’ for travel in those countries where required.
4. What are the country capabilities in relation to Covid-19?
   1. MRN regularly request the below information from vendors:
      1. The current national and local health authority guidance
      2. A description of any variations to their national and local health authority guidance that the vendor is taking
      3. Information regarding vendor resource/capacity that may impact MRN service
   2. Vendors provide the requested information and MRN is in regular contact during our normal MRN project management process. Vendors make MRN aware of individual visit or patient issues related to COVID 19 during these communications and the dedicated Vendor Management team are monitoring changes to country restrictions. MRN are also monitoring the global Clinical Trial regulatory bodies information sites to ensure MRN are following all guidance.
   3. Specific country updates related to customer ongoing studies can be provided by MRN on request.
5. Are there currently restrictions to Direct to Patient logistics services related to IMP shipment or sample collections?
   1. MRN are working with our logistics partners closely to understand current capabilities per country. Changes are available through website information and through direct contact with vendors as needed. Currently service is being provided with few limitations but with a reduction in national and cross border flights, shipping routes may become restricted and direct drivers will need to be utilized in some situations. Changes in shipping routes may result in unavoidable cost increases per shipment.
6. Do MRN have concerns about resources to conduct HTS visits during the Covid-19 pandemic?
   1. MRN are working closely with our own HCP staff and vendors to understand current capacity and any limitation to service provision. MRN are actively planning back up staff where possible and where national guidelines permit. In our experience HCPs are highly committed to seeing patients and will continue to do so where safe for patient and HCP. Updates will be provided by MRN to customers whose projects are directly affected.

1. How does Brexit affect MRNs staff’s supplies and equipment across the EU?
   1. MRN ensure adequate levels of ancillary stock are kept in our EU distribution hub and all EU healthcare professionals (HCPs) supplies are shipped from this location. In addition, supplies of ancillary stock are stored within our Spanish and German offices.
   2. MRN also has the facility to send equipment from EU based suppliers as needed.
2. Will Brexit cause disruption to studies in terms of data?
   1. MRN can transfer personal data to the EEA from the UK in compliance with EU data protection standards; however, any EEA based organisation sending personal data to MRN in the UK will still be required to comply with GDPR and as such will be required to ensure suitable protection is in place.
   2. For EEA based vendors, MRN already has this in the form of Standard Contractual Clauses (SCCs) and this allows the sending of data relating to nurses to MRN. As MRN has SCCs in place with customers, this ensures that patient data can continue to flow from sites.
3. How will Brexit affect any shipments necessary in studies?
   1. All MRN managed IMP shipping is national and not cross border, so should present no issues.
   2. Samples being shipped into and out of the UK may be delayed, but World Courier do have AEO status in place and have increased their customs brokerage team in the UK to minimise any disruption.